True diligence or conspiracy? WHO's handling of swine flu

A year ago the WHO's director-general declared swine flu a pandemic. Now some medical experts are questioning the WHO decision and the objectivity of the influenza experts whose advice they followed. We examine the WHO's handling of the swine flu pandemic.

The declaration set in motion influenza pandemic plans across the globe. These plans were based on guidelines put together by the WHO in 2004 and 2009. They recommended mass influenza vaccinations and the distribution of antiviral drugs. In Australia, once the pandemic was declared, we purchased 21 million doses of swine flu vaccine, at a cost of around $130 million.

A year on, swine flu hasn't been the deadly pandemic first feared, and large quantities of vaccine and antiviral drugs remain unused. In Australia as of 10th June, only 9 million of those 21 million doses of swine flu vaccine had been distributed.

Now some medical experts are questioning the WHO's decision to declare a pandemic and the objectivity of the influenza experts whose advice they followed.

Two reports came out last month, one by the Council of Europe and the other by the British Medical Journal, criticising the procedures used by the WHO and claiming that a number of the WHO experts have, or have had in the past, financial links with pharmaceutical companies producing antiviral drugs and influenza vaccines.

Hello, I'm Annabelle Quince. Today on Rear Vision, here on ABC Radio National, and the web, we examine these allegations and try to piece together the story of the WHO's pandemic preparedness plan.

Newsreader: There have now been 11 confirmed and 11 suspected cases of the bird flu in Hong Kong.

Man: This is the first case where we've actually seen people becoming directly ill as a result of a bird-transmitted virus. If it does acquire the ability to spread, then almost certainly there will be a pandemic.

Annabelle Quince: The story begins in 1999 following the 1997 outbreak of chicken flu. Dr Deborah Cohen is the features editor for the British Medical Journal, and one of the co-authors of the recent article WHO and the pandemic fly conspiracy.

Deborah Cohen: In 1997 there was a feared chicken flu outbreak in Hong Kong and there were fears it would turn into a pandemic. It didn't, but there were fears that would happen. And so 1999 is quite a pivotal year in many ways, and we had the advent of these new antiviral drugs, Neuraminidase inhibitor, they're called. We know them better as Relenza and Tamaflu, and they were first being approved by the US Food and Drugs Administration. But also the WHO decided to draw up its first pandemic preparedness plan and it did it with a group called the European Scientific Working Group on Influenza.

Now this is where WHO's first relationship if you like, with industry began, because this group, based in Europe, are totally funded by the pharmaceutical industry, specifically companies that make antivirals and also vaccines for influenza. And actually one of the key people, or a couple of the key people that wrote this guidance for the WHO with the European Scientific Working Group on Influenza, were actually promoting Tamaflu in Roche marketing material at the time. And this was never made totally transparent.

Annabelle Quince: What did that scientific body actually advise?

Deborah Cohen: This is when they -- they first started to advise stockpiling of antivirals. Earlier drugs weren't considered to be as effective as these new class of drugs Neuraminidase inhibitor. And it was the first time there was real momentum behind the idea of stockpiling.

Gregory Hartl: There are three different versions of the preparedness plan actually. The first one was developed or published in 1999, the second in 2005 and the third in 2009.

Annabelle Quince: Dr Gregory Hartl is the World Health Organisation's spokesperson on H1N1.

Gregory Hartl: WHO convenes periodically a large cross-section of scientists and other public health specialists to look at the latest state of knowledge on influenza as a virus, on its transmission, on its behaviour, and on the measures which are possible in order to try to prevent and contain and minimise the effects of epidemics or possibly a pandemic of influenza. So science is constantly changing and evolving, and that's why we have had three different versions of the pandemic plan in the light of experience and the light of experience of first the H5M1 appearing in Hong Kong in 1997, led to the development of the 1999 guidelines, then SARS led to the changes to the guidelines in 2005, and then a lot more experience with various aspects of H5N1 and with medicines and with other tools, led to the revision in 2009.

Deborah Cohen: In 2004 the WHO produced definitive guidance about pandemic planning. I mean this was in the advent of avian influenza, and it was when government really started to stockpile in earnest. And this 2004 guidance was based on an earlier meeting in 2002 that occurred in Geneva, and a group of experts were convened to draw up this guidance. Now what we know, that among the people drawing up this guidance were representatives from Aventis, which produce vaccines, and also from Roche. We also know that the three key people charged with writing up this guidance, all three of them were on the payroll of pharmaceutical companies that would be set to benefit from a pandemic.

Gregory Hartl: Those guidelines were the result of an enormously large process. There were 140 scientists approximately, involved in the elaboration of those guidelines. Of those 140 scientists, eight were found or declared some type of connection to pharma companies. The summary of relevant conflicts of interest or potential conflicts of interest is just about to be published, and you will see we are very overt about what happened with the pandemic preparedness guidelines. As I said, it was only eight out of 140 scientists, and then moreover, after the scientists finished the first draft of the pandemic preparedness guidelines, the guidelines were put out for public comment via the web, and we received over 600 comments from 66 countries I believe. So these guidelines were shaped by a very open process that involved experts literally from around the world.

Deborah Cohen: First of all the WHO had their own stringent guidance in place in 2003 that basically said that people with major conflicts of interests should not be involved in drawing up guidance. They have not been published, these major conflicts of interest, and it's not been made publicly known to public health doctors, to the general public, to governments, that actually these are the people that drew up guidance for WHO were on the payroll of pharmaceutical industries. What we have done is we have actually gone to the WHO and said 'Do you have the declaration of interest statements?' Because what they're supposed to do is they're supposed to keep on their books for ten years, any declaration of interest statements. And there is a clause in WHO policy that if the objectivity of guidance is questioned, then they are allowed to release the declaration of interest statements.

We made the request several times to WHO, and that request actually went directly up to Director-General Margaret Chan. But that request was actually turned down.

Gregory Hartl: We do want the best experts and we need the best experts to give us advice, because WHO lives and dies on the quality of the advice it gives to its member states. Now we know that the best experts in the world, like the best football players, would be sought by every team. So you know, if you're Ronaldo or whomever, every team's going to want to have you on your team, and that's the same way with flu experts. We know that flu experts will be sought out also by pharmaceutical industry. So this is why we ask for declarations of interest, and we also however know because influenza's a relatively small community, everyone knows what everyone else is doing. And these declarations of interest are made public at the start of the meeting, any potential relevant interests are discussed and if there is a perceived conflict, that is discussed further with the expert in question, and if it really it deemed to be an actual conflict, then the person would be asked to excuse themselves from the committee.

Deborah Cohen: There's an inherent problem with the influenza community, in the sense that the pharmaceutical industry and public health bodies, and that might be governments making policy decisions or the World Health Organisation, draw on the same pool of experts. But there are ways of militating against any undue influence. But also I think what we have to consider is how objective influenza experts are. Are influenza experts going to turn round at any point and say, 'Well actually, I don't think we should be focusing on attention on influenza'. Health budgets have a limited capacity. If you spend a one drug you're not going to be spend on another drug we call that opportunity cost. Are they ever going to turn round and say, 'Actually, I think we should be concentrating more on' -- I don't know -- 'malaria'? Or 'we should be focusing on investment in cancer.' And so there is an inherent bias there. And also when it comes to public policy, we have to ask are these the best people to draw up public policy? Obviously we need their expertise and I don't think there is any question about that. But what we need is our epidemiologists so people that understand population data, we need health economists, people that understand the budgets, not actually people that know the ins and outs of a specific virus, necessarily, and obviously we need that expertise, but should they be drawing up the final policy? And I think there are questions over that and how that is handled. And I'm not necessarily going to come down categorically on either side, but I do think these are issues that need fleshing out.

Annabelle Quince: You're with Rear Vision on ABC Radio National, and via the web. I'm Annabelle Quince and today we're examining the criticisms made by some medical experts about the way the World Health Organisation has handled the swine flu pandemic.

Tony Eastley: Fear is mounting as a new strain of a killer swine flu spreads around the world. The flu is being blamed for up to 81 deaths in Mexico. Already the new strain of swine flu has spread to the United States and Canada, and there are also suspected cases in New Zealand, Europe, the Middle East and Asia.

Annabelle Quince:The other criticism of the WHO is the way they define a pandemic, focusing primarily on the geographical spread of the virus rather than the severity of it. According to epidemiologist Dr Tom Jefferson from the Cochran Institute in Rome, up until May 2009 the WHO's definition of a pandemic did include the criteria of severity and morbidity but sometime after that it was removed.

Tom Jefferson: Richard Shope, writing in 1958. Shope was the guy who first isolated a swine influenza virus, in the '30s, he gives the same definition as WHO was giving, before May 2009, which is a rapid spread, and enormous numbers or considerable numbers of cases with complications and deaths, and that is the definition which you will find on all text books, including the text book of influenza, and it is a feature of most pandemics, cholera, of yellow fever, or pandemics of most diseases, especially infectious diseases.

Annabelle Quince: And yet this isn't the way the WHO has been defining pandemics in relation to the current swine flu influenza.

Tom Jefferson: That's right. At some stage during the first week in May, 2009, the definition changed and the severity, that's the impact with a high number of cases, complications, and deaths, so-called morbidity and mortality. These disappeared. And all that was left was a spread and concepts of a new virus, which I think is a particularly dangerous definition. Bear in mind also that it's almost impossible to understand now what a definition between an extraordinary event and an ordinary event is. Where the demarcation line between seasonal and pandemic influenza.

Reporter: Twenty cases of swine flu across five states have been confirmed in the US, unlike in Mexico where the same strain is killing people, cases in the US have been mild and US health authorities can't yet explain why. Yet, they've still declared a public health emergency.

Gregory Hartl: There has never been a notion of morbidity in the formal phase definitions. It isn't possible to calculate morbidity in real time, or to find indicators that would be accurate indicators. Moreover, in the course of a pandemic, and in the course of a virus changing, morbidity can well change over the course of a pandemic, so we have not found a way yet to include severity in any meaningful way in our definitions. There has been a lot of work going on in this. For example, when we were doing the revision of the guidelines which eventually came out in 2009, there was a meeting of approximately 200 scientists in May, 2008 in Geneva, that spent an entire day if not two days, talking about how develop indicators for severity which could be used in real time. And they were stumped.

Annabelle Quince: There was, or certainly some people have suggested to me that there was for a time available on the WHO website, something that actually specifically listed enormous numbers of death and illness as a criteria. But that's not right?

Gregory Hartl: That was a description of one possible scenario. But that phrase, yes, that was a web document which went up in 2003, that was a description of a possible scenario, but certainly that was never part of any phase definitions.

Deborah Cohen: Normally, or in years gone past, the pandemic, the definition of pandemic includes the measure of severity, so it's not just the fact that this diseases has spread quite widely geographically, that it's a measure of morality in there, or severity, and this measure of severity was taken out, so the definition of a pandemic hinged much more on geography, geographical spread. And this was actually quite hotly debated at the World Health Assembly in 2009, and that was held in May, and that's the WHO's annual conference, where ministers around the world go. And actually, Alan Johnson, who then was Secretary of State for Health in the UK, raised this issue at the conference, and he said he was concerned that this measure of severity had been taken out. And he also cautioned the WHO about declaring a pandemic because he said it would trigger costly and risky processes.

John MacKenzie: I think most of the evidence is now suggesting that the outbreak was about as severe as the pandemics we saw in '57 and '68.

Annabelle Quince: Professor John MacKenzie chairs the WHO's Emergency Committee that was formed in April 2009 to advise Margaret Chan on the H1N1 virus.

John MacKenzie: And it was more severe than seasonal influenza particularly the fact that it's occurring in -- not in the elderly, as we normally expect, but in people who we're much more concerned about shall we say, in that they're the young, healthy adults who we very often don't quite understand why they're getting ill. The whole process, in a sense, is not predicated with severity, certainly, it's predicated more on speed and countries and how the epidemic spreads, much more so than on severity. The trouble is that in past pandemics, the first wave is not always in the first few cases, not always been particularly severe. So when you find a disease is spreading as rapidly as this was, and which had the hallmarks of being the preliminary, shall we say, to a major pandemic, then I don't think that the WHO have any option but to take the decisions it did. I think if it hadn't taken those decisions, it would have been castigated thereafter for not doing so.

Annabelle Quince: There are thought to be 15 members on the Emergency Committee, however only one member has been named, Professor Mackenzie. The names of the other members have been kept secret. It's this secrecy, according to Deborah Cohen, that has fuelled suspicion about the WHO's decision to declare a pandemic.

Deborah Cohen: What they did in April 2009 is they convened an emergency committee. Now this was a group of experts from around the world, and the chair of it is John MacKenzie, who's an Australian doctor. And it's always been secret. The outputs, the rationale, and the debates have not been totally transparent, and the people, the members of this committee have not been exposed. WHO say once the pandemic is over, that they will name who's on the committee and what their conflicts of interests are. But this emergency committee have been advising Margaret Chan and the WHO on the handling of the pandemic, and a few names have come out. In the course of our investigation we found that Arnold Monto who was one of the authors at this 2004 guidance, was on the emergency committee. And we also know through the Sunshine Act in America, that he had received between $3,000 and $10,000 last year from Glaxo Smith Klein, which makes Rilenza, which is an antiviral, and also vaccines. And other names have come out and they do work with industry, and some of them it's a necessary part of their job, because they work, two of the names, Maria Zambon, and John Wood, work in the UK, and they work very, very closely with the vaccine industry.

Annabelle Quince: So why has the WHO not released the names of the members of the Emergency Committee?

John MacKenzie: The decisions are being made in the face, shall we say, where a lot of drug companies and diagnostic companies would be very interested in finding out more about it, and a lot of pressure will be put on these people in terms of providing information. So the whole concept really is to protect the members of the committee from undue influence, undue pressure, by the drug companies and diagnostic companies. And I think if we look back and thought about this, say with a disease like SARS, then I can see right away how important it would have been for this committee to have been anonymous, because during SARS there's enormous pressure to find out as soon as we could about what were the best diagnostic reagents, what tests should be put in the field, we didn't quite get to the vaccine side, but certainly we were getting down that track towards vaccines also. And with this particular pandemic now, it's more the vaccine side of things. But nevertheless, the whole idea was to have a committee that could make decisions without fear or favour, without being under any pressure from outside influences. Well I can tell you right away that as the only known person in the Emergency Committee, I have never been contacted by any drug company. So certainly there's no way that I'd be pressurised, no-one's bothered calling me, or being in touch. So we don't know of any activities that would warrant the claims suggested by both the BMJ and Council of Europe.

Deborah Cohen: David Salisbury, who works in the Department of Health, he's the head of the UK's immunisation program, he actually was also the head of the WHO's Scientific Advisory Group on vaccination, pandemic vaccination, and he actually told us that he couldn't understand why this group had been kept secret. The WHO argue that it's to do with protecting the experts that are on this group, protecting them from outside influence. And David Salisbury actually said, 'You know, this isn't bio-terrorism, this is pandemic flu.' You can understand the need for a secret committee when there's bio-terrorism, but in pandemic flu when all the other committees were named, it seems a little bit at odds with its own general policy.

Also that has, if you like, fuelled some of the conspiracies because of the lack of transparency. People have speculated particularly when the pandemic turned out not to be as severe as people were worried about. And there's been another criticism, that there's been a tendency for WHO rather than just give the facts and have tended to advocate for certain behaviours and that possibly hasn't helped their cause. But overall it's the lucky transparency that I think generally people are concerned about, because this is such an important body, the World Health Organisation, and they do need to be squeaky clean in the advice that they give.

Annabelle Quince: The advice the WHO gave during the first part of 2009 was consistent with their previous advice: the use of antiviral drugs, and mass vaccination programs.

John MacKenzie: The antivirals were certainly seemed to be one of the avenues to use in the face of the pandemic, providing the viruses , the pandemic virus was going to be acceptable to the antivirals, and the antivirals gave you certainly a breathing space of hope, during which you could then formulate and produce vaccine.

Tom Jefferson: First of all, antivirals are licensed for all types of influenza and sub-types of influenza, so I wouldn't make a distinction like WHO does between H1N1 and any other types of influenza. Otherwise, if we make a distinction, it means that there's this stockpiling, and the administration of antivirals against H1N1 is off-label. In other words, it's not authorised by registration, which is nonsense. Because antivirals both the new type antivirals are registered against all types of influenza A and B.

Secondly, the auditable evidence points to a mild effectiveness. They reduce symptoms by a day, if you've got influenza, and they might curtail the appearance of symptoms in prevention, in chemoprophylaxis. But this should be tested by independent trials against other symptom-relieving drugs. There is no independent available auditable evidence that these antivirals at the moment, cut down the complications, things like bronchitis, pneumonia, hospitalisations, and death. That's where we got to. And it's taken us a long time to get there.

John MacKenzie: Vaccination was always the long-term goal. Antivirals themselves would never have been the be-all and end-all, so in terms of keeping or trying to control the epidemic, or trying to protect people, vaccinations was the obvious and the major goal.

Reporter: The planning has been underway for months for Australia's biggest-ever vaccination roll-out. Today the Federal Health Minister was in Perth for the historic occasion to witness the first-ever swine flu vaccination injections on willing patients.

Federal Health Minister: And I'm really, as I say, delighted to be here to just reaffirm that message of encouraging Australians to take advantage of the vaccination program.

John MacKenzie: Certainly in terms of the immunisation I certainly wholeheartedly believe that is an important avenue and one that we should try and get as many people in the risk groups to be vaccinated, to ensure their safety.

Tom Jefferson: There's potential dangers to everything you give a human being. The question is whether the potential danger is worth the benefit. Pandemic vaccines of the new variety H1N1 I'm not aware that any trials with meaningful outcomes, outcome measures, this is prevention of death and complications, have actually been done, All you've got is these trials which are alright for registration, which are accepted for registration, in which the vaccine is injected into human beings and surrogate outcomes, intermediate incomes, like an antibody response, are measured. The surrogate outcomes have got very unclear meaning, an unclear relationship with field outcomes. We've been calling for an end to this uncertainty and the carrying out of proper large-scale, independent, randomised control trials of some of these in areas where there is uncertainty. Well we haven't got very far.

Annabelle Quince: So do we have any idea across the globe how much has been spent by countries in buying both vaccines and antivirals?

Deborah Cohen: In the UK alone we've spent a billion pounds. JP Morgan have a figure that in vaccines alone came to $10 billion, I mean that's excluding antivirals, and I'm not 100% sure what the total figure is but it certainly runs into billions upon billions of dollars.

John MacKenzie: Again, I think you have to realise that we've seen pandemics in the past where the second wave has been much more serious than the first. Now as it so happened, this particular strain of virus that's causing the current pandemic has been much more stable than we normally see with influenza. But certainly and from past experience, we would have expected the very often the second wave would have been quite, more severe, and so I don't think we could ever have waited to see what's going to happen because if it had got more severe, we would never have had the vaccine in time. So we don't make those decisions early on, and you have a very severe pandemic, you're not going to be able to protect your population. So it's always a very difficult and a very knife-edged decision-making process.

Tom Jefferson: It was an industry waiting for the thing to happen. Industry with a small 'i', governments had invested huge amounts of money on the stockpiles of antivirals, they had contracts, sleeping contracts with vaccines. The researchers have got a major vested interest in making sure that the whole thing was portrayed as the end of the world, and the media of course, bear a large proportion of the responsibility for this.

Deborah Cohen: If the pandemic had been severe, would we be asking these questions? Possibly not we might be asking a different set of questions, but it doesn't mean we're wrong to ask questions about how it was handled at the time.

You know, there is an expression in public health that you plan for the worst, and you hope for the best, which probably is the best policy. But those people that are giving the policy decisions with that power comes a real sense of accountability, and a need to be transparent, about conflicts of interest, and also most importantly, about the science.

Annabelle Quince: Dr Deborah Cohen, features editor for the British Medical Journal, and co-author of WHO, the pandemic flu 'conspiracy'.

Also joining us today were Dr Gregory Hartl, the World Health Organisation's spokesperson for H1N1; Dr Tom Jefferson, from the Cochrane Institute in Rome, and Professor John MacKenzie, chair of the WHO's Emergency Committee.

If you'd like to hear this program again, or to check out our special features page, head for the website.

Thanks to sound engineer Mark Don, and to ABC Archives. I'm Annabelle Quince and this is Rear Vision on ABC Radio National. Thanks for joining us.

Guests

Dr Deborah Cohen

Features Editor for the British medical Journal and one of the co-authors of the recent article, WHO and the pandemic flu "conspiracies".

Dr Gregory Hartl

The World Health Organisation's spokesperson for H1N1.

Dr Tom Jefferson

Epidemiologist, from the Cochrane Institute in Rome.

Professor John MacKenzie

Chair of the WHO Emergency Committee, formed in April 2009 to advise the Margret Chan on the H1N1 virus.